OverviewAs a Regulatory Affairs professional, you will lead regulatory strategy for medical devices and drug-device combinations.
You will serve as the regulatory representative for global project teams and drive interactions with health authorities and Notified Bodies.
You will oversee regulatory activities across the device development lifecycle and ensure compliant submissions.
This role supports Parexel's mission to improve world health by enabling patient access to therapies.
You will work across regions, including EU MDR-focused tasks, in a flexible home/office setup.
ResponsabilitàDevelop regulatory strategies and create technical documentation for medical devices and combination products
Represent regulatory affairs in global project teams and governance meetings
Lead interactions with health authorities and Notified Bodies, including documentation and meeting coordination
Manage regulatory activities throughout device clinical development and marketing authorization lifecycle
Maintain global regulatory databases with up-to-date information
Collaborate with CMC and QA on device change control and global submission requirements
Support internal and external audits related to medical device quality systems
Coordinate with cross-functional teams to ensure timely,



compliant regulatory submissions
Contribute to continuous improvement, innovation, and strategic planning within regulatory function
Requisiti fondamentaliUniversity degree in a scientific discipline or life sciences field; minimum 5+ years of regulatory affairs experience for medical devices and drug-device combinations
In-depth knowledge of global medical device regulations, especially EU MDR; familiarity with US FDA is a plus
Proven experience in global regulatory strategy and technical documentation for EU (clinical investigations, Notified Body opinions, CE certifications)
Familiarity with EU-MDR, ISO *****, ISO *****; experience with in vitro diagnostic devices a plus
Strong track record in regulatory audits and inspections; excellent communication and interpersonal skills
Fluent in English, written and spoken
Proficiency with regulatory systems like Veeva and TrackWise a plus
Excellent communication and interpersonal skills
Cross-functional collaboration
audit and inspection readiness
Regulatory strategy for medical devices and combination products
Regulatory documentation for EU and Notified Bodies
EU MDR knowledge

📌 Regulatory Affairs Consultant: Medical Device And Combination Product Expert (Bardi)
🏢 Parexel
📍 Bardi